The Recall Desk

Archive

January 2018 recalls

494 recalls were announced in January 2018.

What the numbers show

Critical
39
Severe
121
High
177
Moderate
138
Low
19

Of the 494 recalls this month scored against our rubric, 8% are Critical, 24% are Severe.

101–200 of 494

  • CriticalFDA (Food)·F-0686-2018·2018-01-24

    Fieldbrook Foods Recalls Sundae Shoppe Raspberry Cream Ice Cream Bars

    Fieldbrook Foods is recalling Sundae Shoppe Raspberry Cream Ice Cream Bars due to potential Listeria monocytogenes contamination. The product was distributed nationwide, including Puerto Rico.

    Product
    RASPBERRY Cream Ice Cream Bars: Sundae SHOPPE, 12 Bars, UPC 041498204631
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0685-2018·2018-01-24

    Fieldbrook Foods Recalls Chocolate Covered Vanilla Ice Cream Bars

    Fieldbrook Foods is recalling chocolate covered vanilla ice cream bars due to potential Listeria monocytogenes contamination. The products were distributed nationwide, including Puerto Rico.

    Product
    Chocolate Covered Vanilla Ice Cream Bars packaged under the following brands: 12 packs - Ahold UPC: 6 88267 03323 5 and different ICB: 6 88267 08587 1, Econo UPC: 7 08938 00534 9, First Street UPC: 0 41512 11933 0, Food Club UPC: 0 36800 78404 8, Giant Eagle UPC: 0 30034 003
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0567-2018·2018-01-24

    Coconut Tree Shredded Coconut Recalled for Salmonella Contamination

    Evershing International Trading Inc. is recalling Coconut Tree Brand Shredded Coconut after Massachusetts testing detected Salmonella.

    Product
    Coconut Tree Brand Shredded Coconut; frozen Dua Bao; Net WT. 16 oz. (454 g); Product of Vietnam; UPC 05216-44081 Ingredient: Coconut Manufactured by: Lucky Shing Co., LTD 108/1 Road No. 830, Hamlet No. 3 An Thanh Village, Ben Luc District Long An Province, Vietnam.
    Category
    Food
    Distribution
    10 states
  • CriticalFDA (Food)·F-0576-2018·2018-01-24

    H.I.G. Corporation Recalls Frozen Tuna Fillet Saku Due to Listeria

    H.I.G. Corporation is recalling 522 cases of frozen tuna fillet saku because customer testing detected Listeria monocytogenes.

    Product
    Frozen Tuna Fillet Saku (Restaurant Supply Only); 22 lbs./2 x 5 kgs. Wild caught: Handline with Hook. Keep Frozen - 18 degrees C or below Product of Indonesia; Packed for H.I.G. Corporation. Carson, CA
    Category
    Food
    Distribution
    33 states
  • CriticalFDA (Food)·F-0687-2018·2018-01-24

    Fieldbrook Ice Cream Variety Packs Recalled for Listeria Contamination Risk

    Fieldbrook Foods is recalling ice cream variety packs due to potential Listeria monocytogenes contamination. The products were distributed nationwide, including Puerto Rico.

    Product
    Ice Cream Variety Packs containing Sandwiches, Bars, and Cones, Sold under the following: 30 pack - pics BY PRICE CHOPPER - UPC: 041735080295; STARTER BROS Ice Cream Favorites Variety Pack, UPC: 074175850111; WELLSLEY FARMS ICE CREAM TREATS VARIETY PACK, UPC: 888670020487; STONE
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalUSDA FSIS·006-2018·2018-01-24

    Rich Products Recalls Beef Meatballs Due to Possible Listeria Contamination

    Rich Products Corporation is recalling approximately 3,420 pounds of frozen beef meatballs that may be contaminated with Listeria monocytogenes.

    Product
    Rich Products Corporation Recalls Beef Products due to Possible Listeria Contamination
    Category
    Food
    Distribution
    9 states
  • CriticalFDA (Food)·F-0684-2018·2018-01-24

    Fieldbrook Foods Recalls Orange Cream Ice Cream Bars for Listeria Risk

    Fieldbrook Foods is recalling Orange Cream Ice Cream Bars sold under multiple brand labels due to potential Listeria monocytogenes contamination.

    Product
    Orange Cream Ice Cream Bars sold under the following labels: Sold in a 12-pack: Ahold UPC: 6 88267 03292 9, Econo UPC: 7 08938 00610 0, First Street no OCB s, Food Club UPC: 7 08938 00610 0, Giant Eagle UPC: 0 30034 00337 1, Great Value no OCB s, Greens UPC: 0 71441 03
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0696-2018·2018-01-24

    Hong Chang Corporation Recalls Un-eviscerated Dried Anchovy Product

    Hong Chang Corporation is recalling 515 cases of Hanryosued (F. Dashi Anchovy) because the dried fish was un-eviscerated or partially eviscerated.

    Product
    Hanryosued (F. Dashi Anchovy) 1.5kg x pack/carton UPC 826546102745, 826546102378
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Devices)·Z-0350-2018·2018-01-24

    Merge Healthcare Recalls Power Strips in Hemo System Due to Overheating

    Merge Healthcare is recalling 1,150 power strips sold with the Merge Hemo System because an input resistor can overheat and cause the unit to smoke.

    Product
    Fellows "Mighty 8" Power strip (Part Number 04175-0008) and TrippLite Power strip (PS-415-HGULTRA - Part Number 13-00106-00) are two components sold as part of the Merge Hemo System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0224-2018·2018-01-24

    Rugby Diocto Liquid Recalled for Microbial Contamination

    PharmaTech LLC is recalling Rugby Diocto Liquid due to microbial contamination, including yeast and potential B. cepacia.

    Product
    Rugby Diocto Liquid, Docusate Sodium 50 mg/ 5 mL, Stool Softener Laxative, One Pint (473 mL) plastic bottles, Dist. by: Rugby Laboratories, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 --- NDC: 0536-0590-85, Manufactured by PharmaTech LLC, Davie, FL
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0227-2018·2018-01-24

    Rugby Aller-chlor Syrup Recalled for Microbial Contamination

    Pharmatech LLC is recalling Rugby Aller-chlor syrup due to microbial contamination, including yeast and potential B. cepacia.

    Product
    Rugby Aller-chlor (Chlorpheniramine Maleate Syrup, USP), 2 mg, 4 fl. oz. (120 mL) plastic bottles, Distributed by: Rugby Laboratories 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152 USA --- NDC: 0536-1025-47, Manufactured by PharmaTech LLC, Davie FL
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-0580-2018·2018-01-24

    Polly Ann Mango Ice Cream Bar Recalled for Undeclared Milk Allergen

    California Popsicle, Inc. is recalling Polly Ann Mango Ice Cream Bars due to an undeclared milk allergen. The product was distributed in New York, California, and Canada.

    Product
    Polly Ann Mango Ice Cream Bar 4 BARS-2.5 FL. OZ. (75mL) TOTAL 10 FL. OZ. (300mL) UPC 7 00730 28866 1
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-0579-2018·2018-01-24

    Polly Ann Red Bean Ice Cream Bar Recalled for Undeclared Milk Allergen

    California Popsicle, Inc. is recalling Polly Ann Red Bean Ice Cream Bars because they contain undeclared milk, a major food allergen.

    Product
    Polly Ann Red Bean Ice Cream Bar 4 BARS-2.5 FL. OZ. (75mL) TOTAL 10 FL. OZ. (300mL) UPC 7 00730 26868 7
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-0569-2018·2018-01-24

    Bellisio Michelina's Fettuccine Alfredo Recalled for Undeclared Soy

    Bellisio Foods is recalling Michelina's Fettuccine Alfredo packages due to undeclared soy. The recall follows a consumer report of chicken in the product, which contains soy.

    Product
    Michelina's Fettuccine Alfredo NET WT. 8.5 oz package Frozen CONTAINS MILK, WHEAT BELLISIO FOODS, INC., DULUTH, MN 55802 UPC 7 17854 10501 9
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Drugs)·D-0226-2018·2018-01-24

    Rugby Senexon Liquid Recalled for Microbial Contamination

    Pharmatech LLC is recalling Rugby Senexon Liquid due to microbial contamination, including yeast and potential B. cepacia.

    Product
    Rugby Senexon Liquid Natural Vegetable Stimulant,(Sennosides) 8.8 mg, 8 fl oz (237 mL) plastic bottles, Distributed by: Rugby Laboratories, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152 --- NDC 0536-1000-59 ; ALSO LABELED AS Major Senna Syrup Natural Vegetable Laxative
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0221-2018·2018-01-24

    Pharmedium Recalls Superpotent Phenylephrine Syringes Nationwide

    Pharmedium Services is voluntarily recalling 2,390 syringes of Phenylephrine HCL 100 mcg/mL due to a superpotent drug classification.

    Product
    Phenylephrine HCL 100 mcg per mL (1 mg/10 mL) in 0.9% Sodium Chloride 10 mL syringes, PharMEDium Services, LLC 913 N Davis Ave Cleveland, MS, NDC 71019-263-20
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0225-2018·2018-01-24

    Rugby Diocto Syrup Recalled for Microbial Contamination

    Pharmatech LLC is recalling Rugby Diocto Syrup due to microbial contamination, including the presence of yeast and potential B. cepacia.

    Product
    Rugby Diocto Syrup, Docusate Sodium 60 mg/15 mL, Stool Softener Laxative, One Pint (473 mL) plastic bottles, Dist. by: Rugby Laboratories, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152. NDC: 0536-1001-85, Manufactured by PharmaTech LLC, Davie, FL
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0353-2018·2018-01-24

    Zoll LifeVest Wearable Defibrillator Recalled for Defibrillation Shock Failure Risk

    Zoll Manufacturing Corp. is recalling 33,670 LifeVest Wearable Defibrillators due to an incorrect service code that may prevent the device from detecting critical defects, potentially leading to defibrillation shock failure.

    Product
    LifeVest Wearable Defibrillator Model 4000, Product Number 10A0988-A01. The LifeVest system is indicated for patients 18 years of age and older who are at risk for sudden cardiac arrest and are not candidates for or refuse an implantable defibrillator.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0380-2018·2018-01-24

    RayStation 6 Proton QA Module Recall for Potential Dosage Errors

    RaySearch Laboratories is recalling RayStation 6 software due to a defect in the proton QA module that may result in incorrect patient dosage calculations.

    Product
    RayStation Product Usage: is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to admin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0588-2018·2018-01-24

    New Punjab Sweets Recalls Sakkar Para for Undeclared Wheat and Milk

    New Punjab Sweets Inc. is voluntarily recalling Sakkar Para due to undeclared wheat and milk allergens. The product was distributed in Illinois and Wisconsin.

    Product
    Sakkar Para, 1 lb. clear plastic clamshell containers.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0583-2018·2018-01-24

    New Punjab Sweets Recalls Besan Ladoo for Undeclared Wheat and Milk

    New Punjab Sweets Inc. is voluntarily recalling Besan Ladoo due to undeclared wheat and milk allergens. The product was distributed in Illinois and Wisconsin.

    Product
    Besan Ladoo, 1 lb. clear plastic clamshell containers.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0348-2018·2018-01-24

    Philips Recalls ECG Out Cables Due to Electrical Interference Risk

    Philips is recalling specific ECG out and sync cables because electrical interference may cause monitors to misinterpret signals or disable monitoring.

    Product
    ECG Out Cable - Heartstart MRx M1783A/M5526A 12-pin Sync cables All units of Philips sync cables model M1783A and M5526A as well as Philips ECG out cables model 989803195641. Manufactured - September 4, 2002 October 8, 2014
    Category
    Medical Device
    Distribution
    0 states
  • HighNHTSA·18E005000·2018-01-24

    Fuel Helmets Recalling Specific Models Due to Strap Failure Risk

    Fuel Helmets is recalling specific models because the securing strap may fail in extreme temperatures, increasing injury risk in a crash.

    Product
    EQUIPMENT:MOTORCYCLE:HELMETS recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0220-2018·2018-01-24

    Pharmedium Recalls Subpotent Ephedrine Sulfate Syringes Nationwide

    Pharmedium Services is recalling 5,002 pre-filled ephedrine sulfate syringes nationwide because the drug was subpotent. The voluntary recall was initiated in October 2017.

    Product
    ePHEDrine Sulfate In 0.9% Sodium Chloride, 5 mg per mL (50 mg per 10 mL), 10 mL Total Volume pre-filled syringes, packaged in a) 5-count cartons, NDC 71030-0003-10 and NDC 71030-0003-20, and b) 25-count cartons, NDC 71030-0003-21 and NDC 71030-0003-12, Rx Only, PharMEDium Servic
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0381-2018·2018-01-24

    Owen Mumford Recalls Unifine Pentips Due to Potential Sterility Compromise

    Owen Mumford USA is recalling Unifine Pentips pen needles because water exposure may have compromised sterility. Users should check for discoloration or yellowing of the protective seal.

    Product
    Unifine Pentips 5mm x 31G pen needles, packaged in 100 ct pen needles. Product Usage: Sterile, non-toxic, non-pyrogenic, single use pen needles for the subcutaneous injection of drugs from pen injectors.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0374-2018·2018-01-24

    Boston Scientific Recalls Pacemakers Due to Sensor Signal Issues

    Boston Scientific is recalling PROPONENT DR Pacemakers due to reports of intermittent over-sensing of the Minute Ventilation sensor signal.

    Product
    PROPONENT DR Pacemaker
    Category
    Medical Device
    Distribution
    50 states
  • HighFDA (Devices)·Z-0386-2018·2018-01-24

    Fujifilm Aspire Cristalle Mammography Machine Recalled for Swivel Arm Defect

    Fujifilm is recalling Aspire Cristalle mammography machines because the swivel arm may move down unintentionally.

    Product
    ASPIRE Cristalle (FDR MS-3500) Mammography machine The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500) and Aspire HD-s (FDR MS-2000), generate full-field digital mammography images that can, as other fall-field digital mammography systems, be used for scree
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0572-2018·2018-01-24

    Gel Spice Recalls Beef Bouillon Cubes for Undeclared Soy and Wheat

    Gel Spice Co, Inc. is recalling beef flavored bouillon cubes because they contain undeclared soy and wheat allergens.

    Product
    Spice Supreme Beef Flavored Bouillon Cubes 1.7 oz (48 g) and NET WT. 3-1/2 OZ (98 g) 25 Count
    Category
    Food
    Distribution
    24 states
  • HighFDA (Food)·F-0589-2018·2018-01-24

    New Punjab Sweets Recalls Mixed Sweets for Undeclared Wheat and Milk

    New Punjab Sweets Inc. is voluntarily recalling Mixed Sweets in 1 lb. clear plastic clamshell containers due to undeclared wheat and milk allergens.

    Product
    Mixed Sweets- variety 1 lb. clear plastic clamshell containers.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0575-2018·2018-01-24

    Crown Candy Coconut Bon Bons Recalled for Undeclared Pecan Allergen

    Crown Candy Corporation is recalling Old Fashioned Coconut Bon Bons because intermittent labeling errors caused some tubs to be mislabeled with Pecan Divinity ingredients, resulting in an undeclared pecan allergen.

    Product
    Old Fashioned Coconut Bon Bons; Net Wt. 6.5 OZ. (184g); Manufactured by Crown Candy Corporation; Confectionery product packaged in 6.5 oz. clear plastic tubs with clear plastic lids.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0587-2018·2018-01-24

    Namak Para Recalled for Undeclared Wheat and Milk Allergens

    New Punjab Sweets Inc. is voluntarily recalling Namak Para due to undeclared wheat and milk allergens. The product was distributed in Illinois and Wisconsin.

    Product
    Namak Para 1 lb. clear plastic clamshell containers.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0596-2018·2018-01-24

    Ventura Foods Recalls House Recipe Bleu Cheese Dressing Due to Plastic Foreign Object

    Ventura Foods is recalling 18 cases of House Recipe Bleu Cheese Dressing & Dip because a plastic foreign object was inadvertently introduced into the product stream.

    Product
    plastic cup with foil seal: House Recipe Bleu Cheese Dressing & Dip; Distributed by: Sysco Corporation, Houston, Texas 77077; Net Wt 1.5 OZ.Code: B10127; packed in cardboard case : House Recipe; Distributed By Sysco Corporation; Houston Texas 77077; B10127; HR BluChs 128/1
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0595-2018·2018-01-24

    Ventura Foods Recalls A&W Papa Sauce Due to Plastic Foreign Object

    Ventura Foods is recalling A&W Papa Sauce because a plastic foreign object was inadvertently introduced into the product stream.

    Product
    A&W All American Food Papa Sauce; 8/24 OZ. Pouches; Net Wt 12 LB. Paced Exclusively For Use By: A&W and its franchisees., Lexington, KY 40611; Use by: 04 29 18 and 04 30 18;
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0573-2018·2018-01-24

    Gel Spice Recalls Beef Bouillon Cubes for Undeclared Soy and Wheat

    Gel Spice Co, Inc. is recalling beef flavored bouillon cubes because they contain undeclared soy and wheat allergens.

    Product
    Spice Supreme Beef Flavored Bouillon Cubes 1.7 oz (48 g) and NET WT. 3-1/2 OZ (98 g) 25 Count
    Category
    Food
    Distribution
    24 states
  • HighUSDA FSIS·pha-012418-01·2018-01-24

    USDA Issues Public Health Alert for Uninspected Chicken and Pork Product

    USDA FSIS issued a public health alert for approximately 140 pounds of ready-to-eat chicken and pork product produced without federal inspection. No illnesses have been reported.

    Product
    Carnival Culinary Solutions — FSIS Issues Public Health Alert for Chicken and Pork Products Produced without the Benefit of Inspection
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0577-2018·2018-01-24

    Reef Net Wild Pacific Smoked Salmon Recalled for Undeclared Soy

    Barlean's Fishery is recalling Reef Net brand Wild Pacific Smoked Salmon because the product contains undeclared soy lecithin, a major allergen.

    Product
    REEF NET brand Wild Pacific Smoked Salmon. Product is Ready-To-Eat, hot smoked, vacuum packaged in 1 lb.; 1.5 lbs.; and 2 lbs. package, keep refrigerated or keep frozen. The label is read in parts: "***REEF NET Brand *** Wild Pacific Smoked Salmon***Ingredients: Fish, salt,
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0351-2018·2018-01-24

    Hologic Recalls Affirm Lateral Arm Upright Biopsy Accessory Due to Component Issue

    Hologic, Inc. is correcting 12 Affirm Lateral Arm Upright Biopsy Accessories in the U.S. due to a component issue that could impact needle alignment during lateral biopsy procedures.

    Product
    Affirm Lateral Arm Upright Biopsy Accessory. Product Number: ASY-09880
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0385-2018·2018-01-24

    Fujifilm Aspire HD Plus Mammography Machines Recalled for Swivel Arm Defect

    Fujifilm is recalling Aspire HD Plus and HD-s mammography machines because the swivel arm may drop unintentionally.

    Product
    Aspire HD Plus (FDR MS-2500), also known as Aspire HD Plus F and Aspire HD-s (FDR MS-2000), also known as Aspire HD Plus S). Mammography machine The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500) and Aspire HD-s (FDR MS-2000), generate full-field digita
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0390-2018·2018-01-24

    Philips Ingenuity Core CT Scanner Recall for Fastener Torque Verification

    Philips is recalling one Ingenuity Core CT scanner because certain fasteners cannot be confirmed to be torqued to specification, posing a potential risk of harm if parts become loose during use.

    Product
    Ingenuity Core, (Code 728321) Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    0 states
  • HighNHTSA·18E006000·2018-01-24

    Dainese Recalls AGV Carbon Modular Helmets Due to Chin Bar Defect

    Dainese is recalling 325 AGV Carbon Modular motorcycle helmets because glue may have caused the chin base material to deteriorate, increasing injury risk.

    Product
    EQUIPMENT:MOTORCYCLE:HELMETS recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0598-2018·2018-01-24

    Ventura Foods Recalls Italian Dressing Due to Plastic Foreign Object

    Ventura Foods is recalling single-serve Italian dressing packets because a plastic foreign object was inadvertently introduced into the product stream.

    Product
    Single-serve plastic packet Italian Dressing; Case packing: Sysco Classic Cls Italian 500 12Gm ; 47014SYS; B13017; single-serve plastic packet: Chef's Quality Creamy Italian; Chef's Quality; 60/1.5 OZ Pouches Net Wt 5.6 LB; 16689CHQ, B33317;
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0378-2018·2018-01-24

    Roche Recalls Automated Analyzers Due to Possible Sample Mismatch

    Roche Diagnostics is recalling 2,517 automated laboratory analyzers due to a software limitation that may cause sample mismatches.

    Product
    Brand Name: ¿ cobas c 6000 MODULAR Series System e 601 ¿ cobas c 8000 MODULAR Series System - e 602 ¿ Roche / Hitachi MODULAR Analytics Combination System Model/Catalog/Part Number: MODULAR Analytics E 170 ¿ 03022109001 ¿ 03023109973 ¿ 03739040001 ¿ 03739040692 ¿ 05
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0228-2018·2018-01-24

    Unichem Recalls Divalproex Sodium Tablets Due to Metronidazole Contamination

    Unichem Pharmaceuticals is recalling Divalproex Sodium tablets because metronidazole powder was found in one bottle. The product was distributed nationwide.

    Product
    DIVALPROEX SODIUM — DIVALPROEX SODIUM (DIVALPROEX SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0391-2018·2018-01-24

    Philips Ingenuity Core 128 CT Scanner Recall for Fastener Torque Issues

    Philips is recalling three Ingenuity Core 128 CT scanners because certain fasteners may not have been torqued to specification, posing a potential risk of harm if parts become loose during use.

    Product
    Ingenuity Core 128, (Code 728323) Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0335-2018·2018-01-24

    Hamilton Medical Recalls Intellicuff Standalone Devices Due to Motor Failure

    Hamilton Medical is recalling 176 Intellicuff Standalone devices because the motor may cease to function during use, potentially affecting endotracheal tube cuff pressure.

    Product
    Intellicuff Standalone (PN 951001) Used to continuously measure and automatically maintain the user-set cuff pressure of an endotracheal tube or tracheostomy tube during mechanical ventilation. Used in the ventilation of adults, pediatrics, and neonates.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0388-2018·2018-01-24

    Philips Brilliance iCT Recalled for Potential Fastener Torque Defect

    Philips is recalling 13 Brilliance iCT scanners because certain fasteners may not have been torqued to specification, posing a potential risk of harm if parts become loose during use.

    Product
    Brilliance iCT Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0352-2018·2018-01-24

    Medtronic KYPHON Express Directional Bone Filler Device Recall

    Medtronic is recalling KYPHON Express Directional Bone Filler Devices because the directional arrow may not align with the opening.

    Product
    Medtronic KYPHON(R) Express(TM) Directional Bone Filler Device, SIZE 2, REF FB, QTY 1 EA, Rx only STERILE R
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0574-2018·2018-01-24

    Crown Candy Recalls Pecan Divinity for Undeclared Pecan Allergen

    Crown Candy Corporation is recalling Old Fashioned Pecan Divinity due to intermittent labeling errors that omitted the pecan allergen statement.

    Product
    Old Fashioned Pecan Divinity; Net Wt. 8 OZ. (226g); Manufactured by Crown Candy Corporation; Confectionery product packaged in 8 oz. clear plastic tubs with removable clear plastic lids.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0389-2018·2018-01-24

    Philips Brilliance 64 CT Scanner Recalled for Fastener Torque Issues

    Philips is recalling one Brilliance 64 CT scanner because certain fasteners may not be torqued to specification, posing a potential risk of harm if parts become loose.

    Product
    Brilliance 64, (Code 728231) Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0585-2018·2018-01-24

    New Punjab Sweets Recalls Badusha for Undeclared Wheat and Milk Allergens

    New Punjab Sweets Inc. is voluntarily recalling 10 lbs of Badusha due to undeclared wheat and milk allergens. The product was distributed in Illinois and Wisconsin.

    Product
    Badusha, 1 lb. clear plastic clamshell containers.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0387-2018·2018-01-24

    Phadia 1000 Instrument Recalled Due to Retry Command Malfunction

    Phadia US Inc is recalling 70 Phadia 1000 Instruments nationwide because a malfunctioning Retry command may cause solution shortages and affect test results.

    Product
    Phadia 1000 Instrument, Article Number 12-3800-01.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0382-2018·2018-01-24

    Owen Mumford Recalls Unifine Pentips Pen Needles Due to Sterility Concerns

    Owen Mumford USA is recalling Unifine Pentips pen needles because water exposure may have compromised sterility. Consumers should check for discoloration on the protective seal.

    Product
    Unifine Pentips 5mm x 31G pen needles, packaged in 30 ct pen needles. Product Usage: Sterile, non-toxic, non-pyrogenic, single use pen needles for the subcutaneous injection of drugs from pen injectors.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0338-2018·2018-01-24

    Spineart Recalls Tryptik 2 C-Plate Screws Due to Labeling Error

    Spineart SA is recalling Tryptik 2 C-Plate self-tapping screws because the product labeling incorrectly displays a sketch of a self-drilling screw.

    Product
    TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 16 MM, REF TRY-PS-40 16-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0215-2018·2018-01-24

    Shiseido Sunscreen Recalled for Manufacturing Quality Deviations

    Shiseido America Inc. is recalling Future Solution LX Universal Defense SPF 50+ sunscreen because the manufacturing of active ingredient material did not meet GMP and quality requirements.

    Product
    Shiseido Future Solution LX Universal Defense SPF 50+ (octinoxate 4.9%, octocrylebe 3.0%, oxybenzone 1.0% and zinc oxide 15.4%), packaged in a) 2mL, b) 15 mL and c) 50 mL tubes, Shiseido Americas Corporation Dist. New York, NY 10022. NDC 58411-256-60
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0214-2018·2018-01-24

    Shiseido Recalls bareMinerals Sunscreen Lotion Due to GMP Deviations

    Shiseido America Inc. is recalling bareMinerals Broad Spectrum SPF 50 Daily Prep Lotion because the manufacturing of active pharmaceutical ingredients did not meet GMP and quality requirements.

    Product
    bareMinerals Broad Spectrum SPF 50 Daily Prep Lotion (zinc oxide 23.8%, titanium dioxide 4.1%), 40 mL/1.35 fl. oz. bottle, Dist. by Bare Escentuals Beauty, Inc. SF, CA 94105 USA, NDC 98132-761-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0347-2018·2018-01-24

    Stryker Recalls Trevo XP ProVue System Due to Carton Mismatch

    Stryker Neurovascular is recalling one Trevo XP ProVue System kit because the carton sleeve did not match the physical contents of the pack.

    Product
    Trevo XP ProVue System kit containing 1) Trevo XP ProVue Retriever, 4x20mm and 2) Trevo Pro18 Microcatheter
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0383-2018·2018-01-24

    TEI Biosciences Recalls PriMatrix Acellular Dermal Tissue Matrix Due to Labeling Errors

    TEI Biosciences is recalling 4,081 units of PriMatrix acellular dermal tissue matrix because some Instructions for Use contained missing or duplicate pages.

    Product
    PriMatrix¿ is an acellular dermal tissue matrix derived from fetal bovine dermis. The device is supplied sterile in a variety of sizes to be trimmed by the surgeon to meet the individual patient's needs.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0222-2018·2018-01-24

    AvKARE Recalls Lovastatin Tablets Due to Dissolution Failures

    AvKARE Inc. is recalling 237 cartons of Lovastatin Tablets USP, 40 mg, because annual stability testing revealed low dissolution results.

    Product
    Lovastatin Tablets USP, 40 mg, 50 Tablets (5x10) Unit Dose carton, Rx only, Manufactured for AvKARE, Inc. Pulaski, TN 38478, NDC 50268-512-15.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0216-2018·2018-01-24

    Shiseido Future Solution LX Discovery Set Recalled for GMP Deviations

    Shiseido America Inc. is recalling the Future Solution LX Discovery Set because the manufacturing of active pharmaceutical ingredients did not meet GMP and quality requirements.

    Product
    Shiseido Future Solution LX Discovery Set contains SPF 50+ (octinoxate 4.9%, octocrylebe 3.0%, oxybenzone 1.0% and zinc oxide 15.4%), packaged in 15 mL tubes, Shiseido Americas Corporation Dist. New York, NY 10022,
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0756-2018·2018-01-24

    Paris Foods Recalls Seasoning Blend Due to Pesticide Residue Risk

    Paris Foods Corporation is recalling a specific lot of seasoning blend because it may be contaminated with a chemical pesticide residue.

    Product
    Seasoning Blend- S.E. Meats (Diced red peppers, green peppers, celery and onions) Net weight 1300 LB in TOTE (Plastic liner, corrugated totes)
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0218-2018·2018-01-24

    Shiseido Future Solutions LX Triple Points Bonus Recalled for GMP Deviations

    Shiseido America Inc. is recalling Shiseido Future Solutions LX Triple Points Bonus because the manufacturing of the active pharmaceutical ingredient did not meet GMP and quality requirements.

    Product
    Shiseido Future Solutions LX Triple Points Bonus contains SPF 50+ (octinoxate 4.9%, octocrylebe 3.0%, oxybenzone 1.0% and zinc oxide 15.4%), packaged in 15 mL tubes, Shiseido Americas Corporation Dist. New York, NY 10022, NDC 58411-256-60
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0590-2018·2018-01-24

    Ventura Foods Recalls French Dressings Due to Plastic Foreign Object

    Ventura Foods, LLC is recalling various French dressings because a plastic foreign object was inadvertently introduced into the product stream.

    Product
    Classic Gourmet Dressing; Country French; Net Wt 1.5 OZ.; Ventura Foods, LLC, Lot codes: 33317; Culinary Secrets Country French Dressing; Net Wt. 1.5 OZ.; Lot Codes: 04 29 18; Sysco Reliance French Style Dressing; Net Contents 1 GAL; Lot codes: B12817; Gordon Choice California-St
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0593-2018·2018-01-24

    Ventura Foods Recalls Sysco Imperial Glazed Hot Bacon Dressing Due to Plastic Foreign Object

    Ventura Foods is recalling Sysco Imperial Glazed Hot Bacon Dressing because a plastic foreign object was inadvertently introduced into the product stream.

    Product
    Sysco Imperial Glazed Hot Bacon Dressing; Net Contents 1 GAL; Distributed by Sysco Corporation, Houston, Texas 77077; Code: B12917
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0384-2018·2018-01-24

    Valeant Recalls SPAG-2 Nebulizers for Particle Size Failures

    Valeant Pharmaceuticals is recalling 418 SPAG-2 units and 808 nebulizers because some units failed to meet particle size specifications for ribavirin aerosol administration.

    Product
    Small Particle Aerosol Generator Model SPAG-2 6000 Series (SPAG-2). The SPAG-2 medical device is a pneumatic flow system indicated for the administration of Virazole (ribavirin) aerosol. Driven by a pressurized gas (air or blended oxygen) and uses a nebulizer to generate a fine a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0349-2018·2018-01-24

    Zimmer Biomet Recalls Persona Partial Knee Finishing Guides

    Zimmer Biomet is recalling 158 Persona Partial Knee System Size 8 Finishing Guides because they may not adequately account for shape differences, potentially causing additional surgery time or knee tightness.

    Product
    Persona Partial Knee System, Size 8, Finishing Guide
    Category
    Medical Device
    Distribution
    16 states
  • ModerateFDA (Food)·F-0594-2018·2018-01-24

    Ventura Foods Recalls Tartar Sauces Due to Plastic Foreign Object

    Ventura Foods is recalling specific lots of Imperial, Classic Gourmet, and Culinary Secrets tartar sauces because a plastic foreign object was introduced into the product stream.

    Product
    Sysco Imperial Tartar Sauce; Net Contents 1 GAL; Distributed by Sysco Corporation, Houston, Texas 77077; Code: 12817; Classic Gourmet Dressings Select Tartar Sauce; Net Contents 1 Gal.; Ventura Foods, Brea, CA 92821; Code 05 30 18; . Culinary Secrets Deluxe Tartar Sau
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0341-2018·2018-01-24

    Spineart Recalls Tryptik 2 C-Plate Screw Due to Labeling Error

    Spineart SA is recalling 15 units of Tryptik 2 C-Plate Self Tapping Screws because the product labeling incorrectly displays a sketch of a self-drilling screw.

    Product
    TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 16 MM, REF TRY-PS-45 16-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0337-2018·2018-01-24

    Spineart Recalls Tryptik 2 C-Plate Screws Due to Labeling Error

    Spineart SA is recalling 120 units of Tryptik 2 C-Plate Self-Tapping Screws because the product labeling incorrectly displays a sketch of a self-drilling screw.

    Product
    TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 14 MM, REF TRY-PS-40 14-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0217-2018·2018-01-24

    Shiseido Eye and Lip Collection Recalled for GMP Deviations

    Shiseido America Inc. is recalling the Future Solution LX Luxurious Eye & Lip Collection because the manufacturing of active pharmaceutical ingredients did not meet GMP and quality requirements.

    Product
    Shiseido Future Solution LX Luxurious Eye & Lip Collection contains SPF 50+ (octinoxate 4.9%, octocrylebe 3.0%, oxybenzone 1.0% and zinc oxide 15.4%), packaged in 15 mL tubes, Shiseido Americas Corporation Dist. New York, NY 10022
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0592-2018·2018-01-24

    Ventura Foods Recalls Honey Mustard Dressing Due to Plastic Foreign Object

    Ventura Foods is recalling specific lots of honey mustard dressing because a plastic foreign object was inadvertently introduced into the product stream.

    Product
    Gordon Choice Honey Mustard Dressing; Net Contents 128 FL OZ; For Distribution Exclusively For Gordon Food Service, Wyoming, MI 49509 ; Code: 33217.; Honey Mustard Dressing; Keep refrigerated; Net Content 1 Gallon; Ventura Foods, Brea, CA 92821, dtd: 053018; Sysco Reliance Honey
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0597-2018·2018-01-24

    Ventura Foods Recalls House Recipe Ranch Dressing Due to Plastic Foreign Object

    Ventura Foods is recalling 117 cases of House Recipe Ranch Dressing & Dip because a plastic foreign object was inadvertently introduced into the product stream.

    Product
    plastic cup with foil seal: House Recipe Ranch Dressing & Dip; Distributed by: Sysco Corporation, Houston, Texas 77077; Net Wt 1.5 OZ.Code: B10127; packed in cardboard case : House Recipe; Distributed By Sysco Corporation; Houston Texas 77077; B10127; HR Rch 128/1.5 oz; 30
    Category
    Food
    Distribution
    Distributed nationwide

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